RecruitingNot ApplicableNCT06581302

Magnetic Seizure Therapy for Psychotic Disorders

Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

50 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Psychotic Disorders

Summary

This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

(1) meets the diagnostic criteria for schizophrenia or other primary psychotic disorders according to DSM-5;
(2) age range between 18 and 55 years;
(3) Positive And Negative Syndrome Scale (PANSS) score≥60;
(4) to provide informed consent.

Exclusion Criteria10

(1) have a concomitant severe medical illness;
(2) are pregnant or intend to get pregnant during the study;
(3) have a history of DSM-5 diagnosis of substance dependence or abuse within the past three months;
(4) history of traumatic brain injury (with a screening scale score of 7 or above);
(5) history of poor response to electroconvulsive therapy or MST;
(6) have probable dementia based on study investigator assessment; have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
(7) presenting with a medical condition, medication, or laboratory anomaly deemed by the investigator to potentially induce psychotic symptoms, or significant cognitive impairment. (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
(8) have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
(9) a score of 18 or more on the 24-item Hamilton Depression Rating Scale (HAM-D);
(10) needing ECT treatment immediately due to such dangerous symptoms as suicide, stupor or psychomotor agitation, etc.

Interventions

DEVICEMagnetic seizure therapy by Magnetic stimulator

The seizure is induced by Magnetic stimulator of MagPro MST(XP)，MagVenture A/S, Farum, Denmark. It is administered in combinations with antipsychotic medications

DRUGAntipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)

It mainly includes second-generation antipsychotic medications, such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc, but except clozapine.